Complex abdominal wound care presents many challenges for healthcare professionals and patients. Particularly difficult to manage are enteric or intestinal fistulas which drain the contents of the bowel into open abdominal wounds. Fistulas are abnormal passages between organs that do not normally connect. In cases of intestinal fistulas, a passage from the intestines to the surface of the skin allows intestinal contents or effluent to spill onto a wound site and surrounding skin leading to infection, persistent tissue inflammation, and potentially sepsis. An intestinal fistula can produce seven liters or more of intestinal effluent per day that must be contained and controlled if the wound is to heal.
Intestinal fistulas often lie within a much larger abdominal wound bed. Abdominal wounds with fistulas can encompass large areas of the abdomen, measuring 20 centimeters or greater in diameter and 6 cm or more in depth. Malnutrition, frequent infectious complications, chronic pain, and depression are common in patients with this overwhelming condition. Operative management often requires lengthy procedures of six to ten hours with high risk of morbidity and mortality. To achieve good outcomes, operative repairs generally need to occur six to twelve months after initial identification of the intestinal fistula. Because of the lengthy interval between presentation of the intestinal fistula and definitive surgical repair, intervening wound management takes on a unique importance.
Negative Pressure Wound Therapy (NPWT) uses a vacuum source to compress wound filler dressings and is commonly applied to complex abdominal wounds to promote healing. NPWT holds promise in managing open wounds with intestinal fistulas; however the effectiveness of NPWT and other wound therapies have been limited by a persistent problem of wound filler dressing failure due to intestinal fistula effluent or gastric juice fouling. As a NPWT vacuum is applied to a wound bed that includes an intestinal fistula, the fistula's effluent is drawn into the NPWT wound filler dressing and across the entire wound bed. The effluent contamination causes tissue breakdown and infection, creates a loss of dressing vacuum seal as the system is overwhelmed with effluent, and necessitates frequent changes of expensive NPWT wound filler dressings.
A number of devices have been proposed to control the effluent and bowel contents from intestinal fistulas, including U.S. patent publications 2010/0145293 to Verhaalen, 2008/0161778 to Steward, and 2008/0287892 to Khan et al.; however none of the references appears to have been commercialized in a way that has practical application at the bedside and intestinal fistula wound dressing failure remains a common problem.
General disadvantages found with the references include: 1. Devices are not adaptable to comprehend the broad spectrum of intestinal fistula and other wound types. Different stages of fistula development and healing have different effluent control demands that are difficult to address with devices that are not tailored to the specific wound. 2. Multi-component devices and multi-step device assembly create complexity for caregivers and may require specialized training or the expertise of a wound specialist. 3. Devices with rigid surfaces are very difficult to seal to the wound bed and are potentially dangerous to the intestine and adjacent tissue. Abdominal wound beds are dynamic and pliable surfaces and in practice we find that fistula effluent quickly finds its way past rigid devices and the wound dressing is fouled. Also, rigid devices tend to be uncomfortable for the patient and can aggravate the wound being treated. 4. Devices with thick containment walls and rigid flanges cannot be placed over fistulas and wounds that are in close proximity to the sides of the wound bed or underneath the edges of the abdominal wall and can cause tissue, intestinal, or other structural damage. 5. Devices that rely on ostomy adhesive to create a seal between the device and the wound site have poor longevity. In practice we find that these adhesives do not adhere to wet, weeping wound beds and adhesion generally fails. As adhesion is lost, fistula effluent is drawn past the device and wound dressing is fouled.
An embodiment of the “isolation component” described in U.S. patent publication 2010/0145293 is demonstrated online at http://www.youtube.com/watch?v=fOGpffzZvSY for use on intestinal fistula patients. However, this device has specific disadvantages. 1. The device is too complex for bedside nurses or homecare nurses to assemble without the help of a wound specialist. 2. The device fails to stay in the desired location when compressed with NPWT. 3. The device does not maintain desired form when compressed with NPWT and effluent is drawn past the device and wound dressing is fouled. 4. Caregivers often give up on the technique after repeated failures.
The present disclosure provides devices improved over the prior patent references and prior products.